IMPLANET has been granted 510(k) clearance in the United States and the CE Mark in Europe to market the new Jazz Claw, a hybrid implant that provides autostable posterior fixation.
IMPLANET Receives 510(k), CE Mark
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According to the May 23, 2016, news release, “Jazz Claw is designed to treat complex degenerative pathologies in adults (kyphosis), a growing indication driven by the aging population. Jazz Claw compliments Implanet’s growing product portfolio devoted to degenerative pathologies, which represent the largest spine surgery market segment. In addition, its autostable characteristics aid in the treatment of adolescent scoliosis with hybrid fixation.”
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, said “Jazz Claw is Implanet’s response to the complex issue of securing the top of constructs in adolescent scoliosis and adult degenerative deformities. This biomechanically challenging area was traditionally treated with pedicle screws or hooks, with inherent drawbacks that the Jazz Claw eliminates. The result of a collaboration with prominent surgical teams, Jazz Claw is a new hybrid solution that provides ease of use, versatility and the power of sublaminar band reduction in a high demand location.”
Ludovic Lastennet, CEO of Implanet, added: “We continue to execute our business plan and product-launch schedule in a timely fashion. Jazz Claw is a major new component of our Jazz Band platform, an implant that supplements our product offering for major deformities and meets a major market demand. In this respect, it should rapidly be adopted by our partners, whether specializing in pediatric or adult degenerative indications.”
Asked how they plan to help adoption of the product, Lastennet told OTW, “We anticipate a very natural adoption of JAZZ Claw by the current JAZZ users simply because they have been looking for a solution for the top of their deformation constructs for a long time now. Today IMPLANET is the only company able to offer them a hybrid solution that combines the versatility, the power, and the ease of use of a sublaminar band along with a thoracic hook to form a claw. We also think that this new implant will help us demonstrate that we are definitely the Band Specialist Company to convert new customers to the use of the JAZZ Systems.”
Implanet does seem to be executing its business plan and product-launch schedule as planned. It has launched two major range extensions this year: JAZZ LOCK in April and JAZZ Claw in May. According to Lastennet, the company will continue to move forward within the next 12 Months and meet major market demand.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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